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In-use physicochemical and microbiological stability of biological parenteral products.
Ricci MS, Frazier M, Moore J, Cromwell M, Galush WJ, Patel AR, Adler M, Altenburger U, Grauschopf U, Goldbach P, Fast JL, Krämer I, Mahler HC. Ricci MS, et al. Among authors: goldbach p. Am J Health Syst Pharm. 2015 Mar 1;72(5):396-407. doi: 10.2146/ajhp140098. Am J Health Syst Pharm. 2015. PMID: 25694415 No abstract available.
Best Practices for Microbial Challenge In-use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations.
Zamiri C, Leiske DL, Hughes PF, Kirwan JP, Der E, Cox E, Warburton R, Goss M, Weiser S, Perez-Brown J, Gopalrathnam G, Liu J, Mehta SB, Shereefa S, Specht S, Aedo SJ, Goldbach P, Jia F, Kuehnle B, Page S, Voeten L, Yi L, Zhu C. Zamiri C, et al. Among authors: goldbach p. PDA J Pharm Sci Technol. 2023 Oct 17:pdajpst.2022.012806. doi: 10.5731/pdajpst.2022.012806. Online ahead of print. PDA J Pharm Sci Technol. 2023. PMID: 37848203
Mannitol/l-Arginine-Based Formulation Systems for Freeze Drying of Protein Pharmaceuticals: Effect of the l-Arginine Counter Ion and Formulation Composition on the Formulation Properties and the Physical State of Mannitol.
Stärtzel P, Gieseler H, Gieseler M, Abdul-Fattah AM, Adler M, Mahler HC, Goldbach P. Stärtzel P, et al. Among authors: goldbach p. J Pharm Sci. 2016 Oct;105(10):3123-3135. doi: 10.1016/j.xphs.2016.07.001. Epub 2016 Aug 6. J Pharm Sci. 2016. PMID: 27506270
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